NCT04196920

Methotrexate-associated Anti-TNF Combination Therapy, the Neglected One !

Methotrexate-associated Anti-TNF Alpha (Infliximab/Adalimumab) Combination Therapy: Evaluation of Efficacy and Safety Compared to Traditional Azathioprine-associated Combination Therapy in Patients With Chronic Inflammatory Bowel Disease.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The results of the SONIC trial represented a significant advance in the management of patients with chronic inflammatory bowel disease by demonstrating the superiority of the combination of an alpha TNF anti-TNF with immunosuppressive therapy in naive patients (infliximab and azathioprine) compared to monotherapy in terms of clinical and endoscopic remission (40% versus 22%, p = 0.017). The benefit of this combination therapy is both pharmacological (addition, or even synergy of the two treatments) and immunological (reduction of the risk of immunization to biotherapy). Data on the use of immunosuppressive methotrexate treatment are divergent. Indeed, a previous randomized trial suggested that the combination of anti-TNF alpha including infliximab and methotrexate was no more effective than anti-TNF alpha monotherapy in patients with Crohn's disease. However, the superiority of this combination has been clearly demonstrated over monotherapy in rheumatology for a long time. In practice, more and more practitioners are prescribing this combination (antiTNF and MTX) in IBD patients because of tolerance problems, particularly to azathioprine or in patients with a dual expression of their disease, both digestive and joint. The interest of my thesis work is therefore to be able to clarify these grey areas and to be able to modify or comfort therapeutic choices in practice.

Detailed description

Data will be extracted from medical records (age, gender, smoking status, date of diagnosis of chronic inflammatory disease, date of first prescription of antiTNF alpha either infliximab or adalimumab, date of start and end of immunosuppressive azathioprine/6MP and/or metrotrexate, mode of administration of per os or SC/IV treatment, efficacy based on validated clinical scores HBI-PDAI-Mayo, tolerance). A collection will be made on the University Hospital from a computer workstation. An analysis will then be carried out to write the publication secondarily. The data retention period will be one year from November 2019 to November 2020 depending on the duration of this thesis work, which is estimated at one year. Expected results and prospects : " Methotrexate-associated antiTNF alpha combination therapy is as effective and safe as traditional azathioprine combination therapy in patients with IBD. The positive results may in practice lead to changes in our practices and give first priority to this combination therapy with methotrexate. "

Conditions

• Chronic Inflammatory Bowel Disease

Timeline

• Start date: 2019-12-20
• Primary completion: 2020-05-01
• Completion: 2020-11-30
• First posted: 2019-12-12
• Last updated: 2020-06-05

Locations

1 site across 1 country: France